Cephalalgia最新文献

{"title":"Communicate your findings with graphical abstract in <i>Cephalalgia</i> : Why and how?","authors":"Cédric Gollion, David Garcia-Azorin","doi":"10.1177/03331024241300883","DOIUrl":"https://doi.org/10.1177/03331024241300883","url":null,"abstract":"","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241300883"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodology of drug trials in migraine: History and suggestions for the future.","authors":"Jes Olesen, Peer Tfelt-Hansen","doi":"10.1177/03331024241298642","DOIUrl":"https://doi.org/10.1177/03331024241298642","url":null,"abstract":"<p><p>There is a multitude of scientific papers and guideline papers on the methodology of drug trials in migraine. Here, we try to condense this into a single paper and to make proposals for future consideration. Literature known by the authors and from reference lists of relevant publications was used for the history. Relevant literature for our proposals was searched on PubMed. The main headings in published guidelines, namely, Patient selection, Trial design, Evaluation of results and Statistics, have remained unchanged over the years. Most of the methodology has remained unchanged but the changes that have taken place are important. Chronic migraine has been studied separately from episodic migraine, children and adolescents distinguished from adults, and migraine without aura from migraine with aura. In trial design, the group comparison design has taken priority over the cross-over design, but the latter is suggested for investigator driven, comparative, dose finding and aura trials because of its superior power. There is a confusing number of possible primary end points: number of migraine attacks, number of migraine days, number of headache days and number of 50% responders in prophylactic trials, whereas two-hour pain free is agreed in acute trials. However, also 24- and 48-hour pain free have been suggested and headache relief is sometimes still used against recommendations. Most bothersome symptom has been requested as a co-primary end point by Food and Drug Administration (FDA). Our future suggestions are meant to provide food for thought for future committee work. We suggest that most bothersome symptom needs to be discussed with FDA as a co-primary end point in acute trials. It could also be discussed whether episodic- and chronic migraine need separate study. Migraine with- and without aura should be studied separately. Furthermore, two-hour pain free should be maintained as the primary end point but the use of stricter outcome parameters should be explored. In prophylactic trials, migraine days are recommended over migraine attacks and over 50% responders. For investigator-initiated trials, comparative trials and proof of concept trials by small companies, the cross-over design with its superior power is still recommended. Finally, the need to lump various guidelines into one major document should be considered. The methodology of drug trials in migraine has been worked out in detail. It is important that these guidelines be followed in all clinical trials. We highlight several issues that merit attention in the future.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241298642"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abstracts of the 20^th Biennial Migraine Trust International Symposium, London UK, 5th to 8th September 2024.","authors":"","doi":"10.1177/03331024241280496","DOIUrl":"https://doi.org/10.1177/03331024241280496","url":null,"abstract":"","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241280496"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.","authors":"B Lee Peterlin, Dale S Bond, Jessica Ailani, David W Dodick, Yingyi Liu, Rosa De Abreu Ferreira, Jonathan H Smith, Brett Dabruzzo, Peter J Goadsby, Joel M Trugman","doi":"10.1177/03331024241299753","DOIUrl":"10.1177/03331024241299753","url":null,"abstract":"<p><strong>Background: </strong>Migraine is associated with obesity. These analyses evaluated weight change with atogepant used as a preventive migraine treatment.</p><p><strong>Methods: </strong>Five atogepant clinical trials in adults with migraine (one phase 2b/3; four phase 3) were included: Three 12-week, randomized, placebo-controlled trials (episodic migraine: two; chronic migraine: one); one 40-week, open-label extension trial and one 52-week, standard care, randomized, long-term safety trial in episodic migraine. Change from baseline in body weight was measured.</p><p><strong>Results: </strong>Mean baseline body mass indexes were 30.0-30.7 kg/m² (pooled episodic migraine [United States only]) and 25.0-25.5 kg/m² (chronic migraine [East Asia, Europe, and North America]). More participants treated with atogepant 60 mg once-daily compared to placebo experienced ≥7% weight loss at any time in the pooled episodic migraine placebo-controlled trials (4.9% vs. 2.8%), chronic migraine placebo-controlled trial (5.8% vs. 2.0%), and pooled open-label extension and long-term safety trials (24.0% vs.14.7% in standard care [long-term safety only]). In the placebo-controlled trials, weight loss with atogepant 60 mg once-daily was observed at week 2 (pooled episodic migraine: -0.32%; chronic migraine: -0.39%), increasing at week 12 (pooled episodic migraine: -1.02%; chronic migraine: -1.50%); compared to weight gain with placebo at week 12 (pooled episodic migraine: +0.49%; chronic migraine: +0.10%). In the long-term episodic migraine studies, weight loss with atogepant 60 mg once-daily was observed at week 4 (long-term safety: -0.42%; open-label extension: -0.76%), increasing at week 40 (long-term safety: -2.38%; open-label extension: -2.09%).</p><p><strong>Conclusion: </strong>Atogepant was associated with modest dose- and duration-dependent weight loss.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers: NCT02848326 (CGP-MD-01); NCT03777059 (3101-301-002); NCT03700320 (long-term safety trial); NCT03939312 (open-label extension trial); NCT03855137 (3101-303-002).</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241299753"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142793991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The incremental burden and healthcare resource utilization among people with migraine in Europe: Insights from the 2020 European National Health and Wellness Survey.","authors":"Astrid Gendolla, Joshua D Brown, Amanda R Mercadante, Sheila Drakeley, Nikoletta Sternbach, Aaron Jenkins, Karin Hygge Blakeman, Gianluca Coppola","doi":"10.1177/03331024241276415","DOIUrl":"https://doi.org/10.1177/03331024241276415","url":null,"abstract":"<p><strong>Background: </strong>Despite the high prevalence of migraine in Europe, there is limited research on the burden among people with migraine.</p><p><strong>Methods: </strong>This cross-sectional survey used patient-reported data from the 2020 European National Health and Wellness Survey in France, Germany, Italy, Spain, and the United Kingdom. The study assessed the sociodemographic characteristics, health-related quality of life, depression, work productivity and activity impairment, and healthcare resource utilization among matched samples of people with diagnosed migraine (n = 3985) and compared to a matched cohort without migraine (n = 7970). The study also analyzed the burden across migraine subgroups stratified by the number of migraine headache days.</p><p><strong>Results: </strong>Lower health-related quality of life, higher depression, increased work productivity and activity impairment, and higher healthcare resource utilization were reported among people with migraine and ≥1 migraine headache days compared to matched people without migraine (all <i>p </i>< 0.001). Additionally, the incremental burden was also observed across migraine subgroups (1-3, 4-7, 8-14, and ≥15 migraine headache days) irrespective of the use of prescription medication compared to the matched controls without migraine.</p><p><strong>Conclusion: </strong>Migraine sufferers with ≥1 migraine headache days experienced worse productivity, lower quality of life, depression, and increased healthcare resource utilization than those without migraine, emphasizing the need for effective management strategies.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241276415"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An evolving machine-learning-based algorithm to early predict response to anti-CGRP monoclonal antibodies in patients with migraine.","authors":"Marina Romozzi, Ammar Lokhandwala, Catello Vollono, Giulia Vigani, Andrea Burgalassi, David García-Azorín, Paolo Calabresi, Alberto Chiarugi, Pierangelo Geppetti, Luigi Francesco Iannone","doi":"10.1177/03331024241262751","DOIUrl":"https://doi.org/10.1177/03331024241262751","url":null,"abstract":"<p><strong>Background: </strong>The present study aimed to determine whether machine-learning (ML)-based models can predict 3-, 6, and 12-month responses to the monoclonal antibodies (mAbs) against the calcitonin gene-related peptide (CGRP) or its receptor (anti-CGRPmAbs) in patients with migraine using early predictors (up to one month) and to create an evolving prediction tool.</p><p><strong>Methods: </strong>In this prospective cohort study<b>,</b> data from patients with migraine who had received anti-CGRP mAbs for 12 months were collected. Demographic and monthly clinical variables were collected, including monthly headache days (MHDs), days with acute medication use, number of analgesics and Headache Impact Test-6. Response rates were categorized as <25%, 26-50%, 51-75% and >75% reduction in MHDs. ML models were trained using random forest algorithm and optimized to maximize the F1 score. ML model performance was also evaluated using standard evaluation metrics, including accuracy, precision and area under the receiver operating characteristic curve (AUC-ROC). Sequential backward feature selection was employed to identify the most relevant predictors for each model. Each model was given 11 baseline data inputs and month-based predictors for months 1, 3 and 6. Each model was then validated against an external test cohort of patients who had received anti-CGRP mAbs for 12 months.</p><p><strong>Results: </strong>Three hundred thirty-six patients treated with anti-CGRP mAbs were included. The external cohort included 93 patients treated with anti-CGRP mAbs. We developed six models to predict 3- 6- and 12-month responses using early predictors. ML-based models yielded predictions with an accuracy score in the range 0.40-0.73 and an AUC-ROC score in the range 0.56-0.76 during internal testing and yielding predictions with an accuracy in the range 0.39-0.64 and an AUC-ROC score in the range 0.52-0.78 when tested against an external test cohort. Shapley Additive explanations summary plots were generated to interpret the contribution of each feature for each model. Based on these findings, a response prediction tool was developed. Each model was run through a backward feature selection to find the most relevant features for the models. The MHDs reduction of the previous data point tends to be the most relevant, while the migraine with aura indicator tends to be the least effective predictor.</p><p><strong>Conclusions: </strong>The response prediction tool utilizing evolving ML-based models holds promise in the early prediction of treatment outcomes for patients with migraine undergoing anti-CGRP mAbs treatment.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241262751"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials.","authors":"Christopher Gottschalk, Pranav Gandhi, Patricia Pozo-Rosich, Suzanne Christie, Cristina Tassorelli, Jonathan Stokes, Yingyi Liu, Lei Luo, Krisztian Nagy, Joel M Trugman, Richard B Lipton","doi":"10.1177/03331024241300305","DOIUrl":"10.1177/03331024241300305","url":null,"abstract":"<p><strong>Background: </strong>We aimed to assess the effects of preventive migraine treatment with atogepant vs. placebo on patient-reported quality of life and functioning.</p><p><strong>Methods: </strong>Analyses of patient-reported outcomes from three 12-week, randomized, placebo-controlled trials evaluating preventive migraine treatment with atogepant 60 mg once-daily: ADVANCE (low-frequency episodic migraine [LFEM], 4-8 monthly migraine days [MMDs] and high-frequency episodic migraine [HFEM], 8-14 MMDs), PROGRESS (chronic migraine, CM) and ELEVATE (episodic migraine in those previously failed by two to four classes of oral preventive treatments).</p><p><strong>Results: </strong>Least squares mean differences (95% confidence interval (CI)) in change from baseline were greater (<i>p </i>< 0.05) for atogepant vs. placebo for Migraine-Specific Quality of Life questionnaire Role Function-Restrictive domain scores at week 12 (ADVANCE: LFEM 12.0 (95% CI = 6.0-18.0), HFEM 9.9 (95% CI = 3.4-16.4); PROGRESS: 6.2 (95% CI = 2.5-9.8); ELEVATE: 17.7 (95% CI = 13.1-22.3)), for Headache Impact Test-6 total scores at week 12 (ADVANCE: LFEM -4.7 (95% CI = -6.7 to -2.7); HFEM -3.4 (95% CI = -5.5 to -1.2); PROGRESS: -2.8 (95% CI = -4.1 to -1.4); ELEVATE: -6.5 (95% CI = -8.3 to -4.7)) and for Activity Impairment in Migraine-Diary-Performance of Daily Activities scores across 12 weeks (ADVANCE: LFEM -2.3 (95% CI = -3.9 to -0.7), HFEM -4.5 (95% CI = -6.9 to -2.2); PROGRESS: -3.4 (95% CI = -5.3 to -1.5); ELEVATE: -4.7 (95% CI = -6.4 to -3.1)).</p><p><strong>Conclusions: </strong>Preventive migraine treatment with atogepant 60 mg once-daily vs. placebo improved measures of migraine-related quality of life and functioning among participants with different headache frequencies and histories of previous treatment failure.<b>Trial Registration:</b> ClinicalTrials.gov: NCT03777059 (ADVANCE); NCT03855137 (PROGRESS); NCT04740827 (ELEVATE).</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241300305"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to: \"<i>CLOCK</i> gene circannual expression in cluster headache\".","authors":"","doi":"10.1177/03331024241303592","DOIUrl":"https://doi.org/10.1177/03331024241303592","url":null,"abstract":"","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241303592"},"PeriodicalIF":5.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes, unmet needs, and challenges in the management of patients who withdraw from anti-CGRP monoclonal antibodies: A prospective cohort study.","authors":"Andrea Burgalassi, Marina Romozzi, Giulia Vigani, Roberto De Icco, Bianca Raffaelli, Alberto Boccalini, Francesco De Cesaris, Paolo Calabresi, Pierangelo Geppetti, Alberto Chiarugi, Luigi Francesco Iannone","doi":"10.1177/03331024241273968","DOIUrl":"https://doi.org/10.1177/03331024241273968","url":null,"abstract":"<p><strong>Background: </strong>The anti-calcitonin gene-related peptide (CGRP), or its receptor (CGRP/R) monoclonal antibodies (mAbs), offer targeted, effective, and tolerated drugs for migraine. However, about 25% of patients fail to achieve a clinically meaningful response, usually leading to discontinuation. These patients often have a lengthy migraine history and multiple prior preventive treatment failures, resulting in limited therapeutic options. Herein, we describe the cause for and outcome of withdrawal of anti-CGRP/R mAb and evaluate the treatment course until discontinuation.</p><p><strong>Methods: </strong>We conducted a prospective analysis on migraine patients attending the Florence Headache Center in Italy, who discontinued treatment with anti-CGRP/R mAbs. The primary objectives were to describe the reasons for anti-CGRP mAbs discontinuation and the treatment course. Secondary objectives were the evaluation of the absolute change from baseline in monthly headache days, response rates, persistence in medication overuse, absolute change from baseline of the overall number and days of analgesics use per month, change of MIDAS and HIT-6 at three, six, and 12 months, and the last month of treatment.</p><p><strong>Results: </strong>Among 472 patients, 136 (28.8%) discontinued mAb treatment after an average of 9.0 ± 6.1 (mean ± SD) months. The majority (96/136, 70.6%) discontinued due to ineffectiveness, followed by lost to follow-up during treatment (18/136, 13.1%) and adverse events (10/136, 7.3%). In total, 77.9% of the 136 patients ceased treatment within the first year. Following discontinuation, 48.5% initiated new pharmacological treatment, 39.7% were lost to follow-up, and 11.8% opted not to start another treatment. The majority of patients that started a new pharmacology treatment switched to another anti-CGRP/R (46/68, 67.6%). The second most-used treatment was onabotulinumtoxinA (7/68, 10.2%; all patients in this subgroup were naïve to this treatment), followed by an anticonvulsive medication (7/68, 10.2%). The response status (≥50% reduction in monthly headache days) was achieved by 30.5%, 34.6%, and 40.0% of patients at month 3, 6, and 12 of treatment, respectively. Considering only the comprehensive last month of treatment before withdrawn the percentage of responders was 16.9%.</p><p><strong>Conclusion: </strong>Although anti-CGRP/R mAbs have provided a substantial amelioration of migraine management, a relevant proportion of patients remains unresponsive and requires additional therapeutic support. Further research is required to identify non-responder features and address unmet needs in migraine treatment.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 11","pages":"3331024241273968"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A call for academic pragmatic clinical trials to address open questions in migraine prevention.","authors":"Simona Sacco, Federico De Santis, Agnese Onofri, Chiara Rosignoli, Ghaemeh Nabaei, Matteo Foschi, Raffaele Ornello","doi":"10.1177/03331024241291574","DOIUrl":"10.1177/03331024241291574","url":null,"abstract":"<p><p>The migraine treatment landscape has seen significant advancements in recent years, including the introduction of novel preventive agents specifically targeting the disease. These new treatments offer improved efficacy and tolerability, potentially addressing the issue of poor treatment adherence commonly observed with conventional preventatives. In this context, pragmatic trials emerge as a critical tool for advancing migraine care, offering a real-world approach to evaluating open clinical questions at the same time as avoiding the biases of real-world observational evidence. By prioritizing external validity and patient-centered outcomes, pragmatic trials provide valuable insights into the advantages of new treatments in improving migraine care. Possible applications of pragmatic trials in migraine research include head-to-head comparisons, evaluation of combination therapies, assessment of treatment sequences and switch, testing the added value of patient-reported outcomes, investigation of long-term effectiveness and on optimal treatment duration, understanding the role of preventive treatments in altering the course of migraine and preventing progression, and cost-effectiveness analyses. Pragmatic trials allow for the assessment of interventions in diverse patient populations and healthcare settings, enhancing the generalizability of findings and informing evidence-based clinical practice. As such, pragmatic trials represent an excellent tool to bridge the gap between placebo-controlled trials and real-world practice and should receive consideration for funding, especially by public institutions such as universities, national health services, and charities.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 11","pages":"3331024241291574"},"PeriodicalIF":5.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}